Kornimate/medical-research-clean huggingface dataset:
clinical effects of metformin on fertility-sparing treatment for early endometrial cancer

Conditions: Endometrial Cancer Stage I

Summary: the purpose of the study is to investigate the effects of metformin in addition to the conventional progestin therapy in the fertility-sparing treatment of early stage endometrial cancer.


Eligibility criteria:
inclusion criteria: * endometrial cancer radiologic international federation of obstetrics and gynecology (figo) stage ia patients * endometrioid endometrial cancer patients * figo cellular differentiation grade 1 patients * patients who wish to preserve fertility * patients who understand that the recommended treatment of endometrial cancer is surgical treatment even in early stages, but still wish to preserve fertility and avoid surgical treatment * patients who have good performance status (eastern cooperation oncology group (ecog) performance score equal to or greater than 3) * patients who are not contraindicated to the progestin therapy * patients who are not contraindicated to the use of metformin exclusion criteria: * patients who have already received chemotherapeutic or radiotherapeutic treatments for endometrial cancer * patients whose disease is already advanced and not indicated for fertility-sparing treatment * patients whose tumor cellular differentiation grade is greater than figo grade 1

Keywords: endometrial cancer metformin progestin fertility-sparing treatment
stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in pancreatic adenocarcinoma

Conditions: Pancreas Cancer

Summary: the primary objective of this study is to assess the impact of bethanechol therapy on r0 resection rates. the safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. the exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.

the purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. the chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is fda approved. although bethanechol is fda approved, in this study its use is experimental. the aim of the study is to show that the medication is easy to tolerate and that it shows signs of slowing cancer cell growth. the investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, decrease cd44+ expression in cancer cells, decrease tumor growth rate resulting in an improved r0 resection rate.

Eligibility criteria:
inclusion criteria: * pancreatic ductal adenocarcinoma * plan for neoadjuvant chemotherapy * available diagnostic tissue adequate for biomarker analysis * ability to tolerate po meds and comply with study procedures exclusion criteria: * metastatic disease * evidence of gi obstruction * baseline bradycardia (hr\<55) or hypotension (systolic blood pressure\<90) * use of acetylcholinesterase inhibitors * medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.

Keywords: pancreas pancreatic adenocarcinoma adenocarcinoma bethanechol parasympathetic
safety, tolerability and pharmacokinetics in ad subjects and healthy subjects of cutaneous application of leo 39652 cream

Conditions: Atopic Dermatitis

Summary: the principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when leo 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects or subjects with ad as defined by the hanifen and rajka criteria and with at least mild disease activity (iga \>2) for the whole body * ad lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for ad subjects) * male subjects aged between 18 and 65 years with a body mass index (bmi) between 19.0 and 32.0 kg/m2 inclusive exclusion criteria: * subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects) * subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion. * subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status. * history of or current cardiac arrhythmic disorder * subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer. * subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the investigator
analgesia after knee arthroscopy :dexmedetomidine vs fentanyl

Conditions: Analgesia

Summary: the aim of this study is to evaluate analgesic effects bupivacaine, bupivacaine plus dexmedetomidine and bupivacaine plus fentanyl in relieving pain after knee arthroscopic surgery.

forty-five patients asa i - ii aged 21-45 years for elective knee arthroscopy were divided into 3 groups: group b, bd and bf. group b received intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. group bd received intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug). group bf received intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). the time of first request of analgesia and analgesic effect by vas during the first 24 hr. postoperatively are recorded.

Eligibility criteria:
inclusion criteria: * either sex, * age 21-45 years, * american society of anesthesia (asa) i - ii for elective knee arthroscopy. exclusion criteria: * the patients with history of hepatic and renal diseases, psychiatric disorders, * prolonged intake of (nsaids, opioids and tricyclic antidepressant), * allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

Keywords: dexmedetomidine fentanyl bupivacaine knee arthroscopy postoperative analgesia
a study of 18f-av-45 in healthy volunteers

Conditions: Alzheimer Disease

Summary: this study will determine how florbetapir f 18 (18f-av-45) radioactivity is distributed throughout the body.


Eligibility criteria:
inclusion criteria: * able to lie still on the imaging table for periods up to 1 hour exclusion criteria: * radiation exposure for experimental purposes within the last year * claustrophobic or otherwise unable to tolerate the imaging procedure * medical condition or surgical history that would confound evaluation * current clinically significant cardiovascular disease * received an investigational medication within the last 30 days

Keywords: amyloid imaging positron emission tomography 18f-av-45 florbetapir f 18 diagnostic imaging
long-term safety and efficacy of nemolizumab with moderate-to-severe atopic dermatitis

Conditions: Moderate-to-Severe Atopic Dermatitis

Summary: long-term safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis description

long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe ad

Eligibility criteria:
key inclusion criteria: 1. subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for ad 2. female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection. key exclusion criteria: 1. subjects who, during their participation in a prior nemolizumab study, experienced an ae which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject. 2. pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study. 3. body weight \< 30 kg 4. cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (covid)-19 infection within 2 weeks before the screening or baseline visit. subjects may be rescreened once the infection has resolved. resolution of covid-19 infection can be confirmed by recovery assessment methods. 5. history of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) 6. any clinically significant issue, based investigator judgement
diet intervention treatment for active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.

the etiology of inflammatory bowel disease (ibd), including ulcerative colitis (uc), is complex and poorly understood, but the current hypothesis is that ibd arises from an aberrant immune response to commensal bacteria in a genetically susceptible host, and is triggered by environmental factors. environmental factors such as the microbiome and diet, play a significant role in the risk of ibd. diet has been identified as one of the main drivers of the microbiome composition and the microbiome and diet can work in tandem to affect host physiology. in spite of patient interest in diet and numerous diet studies, currently there is no diet that is clinically validated or universally agreed upon for adult ibd patients. we also lack rigorous studies to show how the microbiome is influenced by diet and affects patient outcomes. we propose to use a sustainable non-elemental diet aimed at altering the microbiome in patients with mild to moderately active uc to alter their disease activity.

Eligibility criteria:
inclusion criteria: * • females and males between the ages of 18 - 75 years of age at the time of enrolment * must have established diagnosis of uc by standard endoscopic, radiographic, or histological criteria * must have active uc defined by having a mayo score equal to or greater than 2 within two months prior to enrollment * must have had \> 10cm involvement at some point in their disease history * fcp\>250 or active endo within 6 months * if a smoker, must not change smoking habits (frequency) during the course of the study * if receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study exclusion criteria: * • uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment * pregnant or lactating females * allergy or intolerance to key or a great number food components of the study diet * current nsaid use * diagnosed with psc * using topical therapies or suppositories * antibiotic use within 4 weeks of the study enrollment or during the study * confirmed c. difficile infection within 3 months of recruitment; * diagnosis of primary psc; * currently using topical therapies or suppositories * history of dysplasia or colorectal neoplasia.
mortality follow-up and analyses of men in the mrfit

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Diabetes Mellitus; Cerebrovascular Accident; Myocardial Infarction

Summary: to extend mortality followup through 25 years for two cohorts of men in the multiple risk factor intervention trial (mrfit): the 361,662 men screened and the 12,866 men randomized, and to pursue the general aim of elucidating unresolved research issues on the epidemiology, natural history, etiology, prevention, and control of major chronic diseases, particularly cardiovascular and neoplastic diseases and diabetes.

background: mrfit was initiated in 1972 as a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (chd) mortality, compared to usual care. follow-up and analysis has continued on the 361,662 men screened and the 12,866 men randomized. design narrative: the national death index (ndi) will be used for continued follow-up of the mrfit cohorts. an additional assay to establish igf-1 and igf binding protein will be added to the data set as a potential prognostic factor. the effort will focus on three primary aims related to long-term mortality. aim 1 will relate nutritional-dietary data to twenty-five year mortality from coronary heart disease (chd), stroke, cardiovascular disease (cvd), colon cancer, prostate cancer, and all causes for the 12,866 men randomized. aim 2 will relate age, ethnicity, socioeconomic position, geographic location, major risk factors, low risk status, prior diabetes, and prior myocardial infarction to twenty-five year mortality for the 361,662 men screened. aim 3 will relate insulin-like growth factor 1 (igf-1), igf binding protein, and fasting and one-hour glucose measurements from frozen baseline sera to mortality for the 12,866 men randomized.

Eligibility criteria:
no eligibility criteria
continuous observation of smoking subject

Conditions: Subjects at High Risk of Lung Cancer Due to Smoking

Summary: the purpose of this study is to offer annual low-dose spiral ct radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.

lung carcinoma is one the most fatal cancer in the world. the enormous fatality rate reflects the limited chance of cure, with a dismal overall 5-year survival rate of approximately 14%. the prognosis of lung cancer depends largely on early detection and immediate treatment prior to metastatic spread. for stage 1 lung cancer the 5-year survival rate can be as high as 70% . these data suggest that early detection and surgical treatment would have a huge beneficial effect on the lung cancer population. we developed a single arm observational study for the early detection of lung cancer with low dose ct scan in high risk asymptomatic subjects. a mainly non invasive algorithm for management of undetermined nodules was designed including low dose ct at three months for baseline nodules with diameter between 5 and 8 mm, a pet scan for nodules larger that 8 mm (not reduced after antibiotics and one month follow up ct). lesions increasing in diameter or in density or positive nodules at ct/pet were sent to surgical biopsy (videothoracoscopic approach preferred). spirometry was done in all subjects prior to ct scan to evaluate correlation between bpco and lung cancer.

Eligibility criteria:
inclusion criteria: * age ≥ 50 * current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked) * former smoker should have stopped smoking within the 10 years before the inclusion in the study protocol exclusion criteria: * not currently suffering from malignant disease or having had malignant disease within the last 5 years * not having known pulmonary pathology * not having performed a chest ct scan during the last 2 years

Keywords: lung nodule screening spiral low - dose computed tomography lung cancer
the role of hs troponin i and nt-probnp in predicting atrial fibrillation in patients with permanent pacemakers

Conditions: Atrial Fibrillation

Summary: the goal of this clinical trial is to answer the research question whether hs troponin i and nt-probnp have a role in detecting atrial fibrillation in patients with pacemakers. objectives of the study: 1. to survey some risk factors for atrial fibrillation in patients with permanent pacemakers. 2. to determine the role of hs troponin i and nt-probnp in predicting new-onset atrial fibrillation within follow-up time. 3. to build a model to predict the prognosis of atrial fibrillation based on the detected subclinical markers related to atrial fibrillation and classic cardiovascular risk factors.

information about age, gender, bmi, medical history, tests to evaluate liver function, kidney function, dyslipidemia, results of echocardiography, ecg, and chest x-ray will be collected from medical records and clinical examination. the hs troponin i and nt-probnp tests will be performed before the patient has a pacemaker. the two tests above will be paid by research team. patients do not have to pay for these tests. atrial fibrillation will be determined through ecg, holter ecg and pacemaker data. time to follow up patients in the study: according to the patient's follow-up visits after pacemaker placement: 1 month, 3 months, 6 months, then every 6 months.

Eligibility criteria:
inclusion criteria: * patient is an adult (≥ 18 years old or older) * there is indication for permanent pacemaker placement and patient agreement to permanent pacemaker placement * patient agrees to participate in the study exclusion criteria: * patients had a diagnosis of atrial fibrillation in their past history or atrial fibrillation is discovered at the time of participating in the study * severe patients, at risk of death * pregnant * the patient is indicated for surgery * patients with egfr ≤ 30 ml/min/1.73m2 * the patient has a serious infection
the influence of a warmed surgical bandage system on subcutaneous tissue oxygen tension after cardiac surgery

Conditions: Cardiac Surgery

Summary: warmed surgical bandage may improve tissue oxygenation and thus on the long run reduce wound infections

wound infections are common and serious complications of anesthesia and surgery. the morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization. the wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections. major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. the primary determinant of tissue oxygen availability is local perfusion. thermoregulatory status is one of the major factors influencing tissue perfusion. local warming induces pre- capillary vasodilation and improves tissue oxygenation. local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. specifically, we will test the hypothesis that warm- up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate exclusion criteria: * emergency surgery * pre - or postoperative on intraaortic balloon pump * preoperative mechanical ventilation * postoperative respiratory failure * postoperative extracorporal membrane oxygenation * left ventricular function \< 40% * fever (core temperature \> 38 °c) or current infection * no anticipated or no definitive primary closure of surgical wound.

Keywords: wound infection tissue oxygen tension local warming
peripheral analgesia in painful diabetic neuropathy

Conditions: Diabetic Neuropathy Peripheral; Neuropathic Pain; Diabetic Foot Infection

Summary: chronic obliterative arteriopathy of the inferior limbs is a frequent condition observed in diabetics. the later stages induce pain at rest and trophic disorders (ulcer, gangrene) that lead to chronic limb ischemia. without possible surgical revascularization ,pain management and tissue healing are used to avoid amputation. prevalence of diabetes is twice higher in reunion island than in metropolitan france. as a consequence, the rate co-morbobidities, such as chronic obliterative arteriopathy of the inferior limbs, is also increases. this study compares the efficiency of two analgesic treatments in diabetics with forefoot injuries.

patients are allocated in two groups regarding : * their eligibility to analgesic treatment using continuous peripheral nerve blocks * the unability of usual pain management to reduce their pain (pain visual analogic scale equal to or more than 4). when patient 's response to pharmacological analgesic treatment is sufficient (pain visual analogic scale equal to or less than 3), patient is allocated to the control group. patients of experimental group received a continous analgesic treatment for 6 weeks using ropivacaine (2mg/ml, flow rate 7 ml/h). patients of control group received an analgesic treatment according the recommended pain ladder of world health organization (who). opioids for mild-to-moderate pain are used in combination with a non-opioid analgesic, such as paracetamol, at the second step of the ladder. if regular maximum doses of opioids for mild-to-moderate pain do not achieve adequate analgesia, then they should be replaced with an opioid for moderate-to-severe pain, such as morphine. efficiency of both treatment is assessed the improvement of oxygen level in the tissue below the skin of the injured forefoot through the study.

Eligibility criteria:
inclusion criteria: * hospitalized patient * diabetics with chronic obliterative arteriopathy of the inferior limbs * permanent limb ischaemia with a tcpo2 of the front-foot of at least 10 mmhg under atmospheric conditions * lack of surgical revascularization * no contraindication to hyperbaric therapy * signed informed consent exclusion criteria: * contraindication to ropivacaine * conditions that could alter hyperbaric measurements (anemia \< 8 g/dl, cardiac or respiratory insufficiency) * patients with planned limb amputation